Treatment with Canagliflozin for 52 Weeks

San Diego—After 52 weeks of treatment, patients with type 2 diabetes who received 100 mg or 300 mg of canagliflozin had reductions in hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), body weight and systolic blood pressure, according to a randomized, double-blind study. The authors noted that the efficacy and safety of canagliflozin were similar at 26 and 52 weeks, suggesting a sustained response.

Results were presented at the EASD meeting in a poster presentation. The poster was titled Efficacy and Safety of Canagliflozin Monotherapy in Subjects with Type 2 Diabetes Mellitus Inadequately Controlled with Diet and Exercise Over 52 Weeks.

The FDA approved canagliflozin in March to be used in combination with diet and exercise in patients with type 2 diabetes. Canagliflozin, an oral medication, is the first FDA-approved drug in a class known as sodium-glucose co-transporter 2 inhibitors. The recommended starting dose of canagliflozin is 100 mg once daily, which can be increased to 300 mg in certain patients.

During a 26-week, randomized, double-blind, phase 3 trial, patients who took 100 mg or 300 mg of canagliflozin had significant improvements in glycemic control and reductions in body weight compared to a group receiving placebo.

This trial was a 26-week extension of that previous 26-week trial. Patients in the canagliflozin groups continued receiving the drug, while those who received placebo in the first 26 weeks switched to 100 mg of sitagliptin for the final 26 weeks.

Of the 584 patients in the first 26-week period, 452 completed the entire 52-week study. The groups were well balanced. The mean age was approximately 55 years, approximately 45% of patients were male and approximately 70% were white.

After 52 weeks, patients in the 100 mg canagliflozin group had a mean reduction in HbA1c of 0.81% and patients in the 300 mg canagliflozin group had a mean reduction in HbA1c of 1.11%. In addition, 52.4% of patients in the 100 mg canagliflozin group and 64.5% of patients in the 300 mg canagliflozin group had an HbA1c <7.0%, while 22.9% and 30.1%, respectively, had an HbA1c <6.5%.

The mean reduction in FPG after 52 weeks was 1.5 mmol/L in the 100 mg canagliflozin group and 2.2 mmol/L in the 300 mg canagliflozin group. Further, after 52 weeks, patients in the 100 mg canagliflozin group had a mean body weight reduction of 3.3%, while patients in the 300 mg canagliflozin group had a mean body weight reduction of 4.4%. In addition, the mean reduction in systolic blood pressure after 52 weeks was 1.4 mmHg in the 100 mg canagliflozin group and 3.9 mmHg in the 300 mg canagliflozin group.

The proportion of patients with adverse events was similar in the groups: 64.1% in the placebo/sitagliptin group, 67.2% in the 100 mg canagliflozin group, and 66.0% in the 300 mg canagliflozin group. Serious adverse events were found in 5.7% of patients in the placebo/sitagliptin group, 5.6% of patients in the 100 mg canagliflozin group, and 2.5% of patients in the 300 mg canagliflozin group.

Two patients in the placebo/sitagliptin group, 6 patients in the 100 mg canagliflozin group, and 4 patients in the 300 mg canagliflozin group had adverse events that led to study discontinuation. During the 52 weeks, there were 3 deaths: 2 in the placebo/sitagliptin group and 1 in the 100 mg canagliflozin group.

This study was supported by Janssen Research & Development, LLC.